Hernia prosthesis with marking means

ABSTRACT

Prosthesis ( 1 ) comprising a patch ( 2 ) made of biocompatible material, said patch having a generally plane geometric shape that defines two opposite faces, a centre, a length and a width of said patch, characterized in that said patch is provided, on one ( 2   a ) of its faces, with a single marking means ( 3 ) designed to indicate both the centre (C) of the patch and also the longitudinal direction of said patch.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.14/366,403 filed Jun. 18, 2014, which is a National Stage Application ofPCT/EP12/076982 under 35USC § 371 (a), which claims priority of FrenchPatent Application Serial No. 11/62536 filed Dec. 29, 2011, and thedisclosures of each of the above-identified applications are herebyincorporated by reference in their entirety.

The present invention relates to a prosthesis, in particular for therepair of hernias, comprising a marking means that makes it easier forthe surgeon to fit the prosthesis in place.

A hernia is a phenomenon that causes a tissue defect in a wall of thehuman body, for example in the abdominal wall. To treat hernias,prostheses have been developed that act as wall reinforcements and thatare intended to fill the tissue defect either temporarily orpermanently. These prostheses are generally in the form of a patchhaving a generally plane geometric shape that defines two oppositefaces. In the case of a hernia of the abdominal wall for example, oneface of the prosthesis is intended to be placed facing the abdominalwall, in order to fill the tissue defect, while the other face isintended to face the abdominal cavity.

These prostheses can be made of porous material, for example abiocompatible openworked textile, with the aim of promoting cellcolonization on the face intended to be placed facing the abdominalwall. In such a case, the face intended to be placed facing theabdominal cavity is generally made smooth and non-porous, for example bya coating of an anti-adhesion material, with the aim of avoiding theformation of post-surgical adhesions to the surrounding organs of theabdominal cavity.

Hernia prostheses can have several shapes, for example rectangular,round or oval, depending on the anatomical structure to which theseprostheses are intended to adapt. In the case of hernias of theabdominal wall, the nature of the tissue defect that is to be treatedmeans that the prostheses more generally have a shape with alongitudinal dimension, such as a rectangle or an oval. Moreover, thedimensions of these prostheses may vary according to the height andbuild of the patient and according to the severity of the hernia. Thus,some of these prostheses can have dimensions of up to 42 cm×32 cm, forexample.

For reasons of efficacy, these prostheses have to be arranged in aspecific and very precise manner in relation both to the defect to betreated and also to the surrounding organs at the time of implantation.It is therefore sometimes useful to provide these prostheses withmarking means aimed at giving the surgeon an indication of theparticular properties of a face of the prosthesis, of its dimensions, orof the location of a precise point of the prosthesis.

Thus, depending on the environment around the implantation site, forexample the presence of viscera, soft tissues, etc., it may be importantto provide the surgeon with indications at a given location of theprosthesis, such that the surgeon can arrange the prosthesis in aparticular orientation or can arrange a certain region of the prosthesisfacing a given organ or, by contrast, as far as possible away from agiven organ, etc.

Hernia prostheses comprising markers or means of information alreadyexist.

However, these means of information are not always easily identifiableor visible to the surgeon, especially when the prosthesis is implantedby laparoscopy.

Indeed, when a prosthesis is fitted in place by laparoscopy, theprosthesis is, for example, introduced into the body of the patient bymeans of a trocar, within which it is generally folded and/or rolled up,and it is then deployed at the implantation site. Although theimplantation site is illuminated in this technique by means of anothertrocar provided for this purpose, and although the surgeon views thissite via a camera, the surgical field visible and accessible to thesurgeon remains limited. In particular, once the prosthesis has beendeployed, it can have a size much greater than the perimeter of thisfield of view. When the means of information present on the prosthesisare distributed over the whole of the prosthesis, the surgeon is forcedto move the latter about in order to find the information for which heis looking, for example in order to identify the face of the prosthesisthat is optionally covered with an anti-adhesion material, or in orderto locate the centre of the prosthesis, or to determine the longitudinaldimension of the prosthesis so as to position it correctly. In somecases, the surgeon may be forced to move the prosthesis several times indifferent directions in order to gather all the information he needs.These manoeuvres for moving the prosthesis about mean that time iswasted, and they can also cause confusion when positioning theprosthesis.

There is therefore still a need for prostheses for hernia repair, inparticular of the abdominal wall, if appropriate of large dimensions,for example of the order of 42 cm×32 cm, which are provided with meansof information that are easily and directly accessible to the surgeon atone glance when fitting these prostheses in place at the implantationsite by laparoscopy, these means of information allowing the surgeon toascertain simultaneously which face of the prosthesis he is dealingwith, the location of the centre of the prosthesis and the longitudinaldirection of the prosthesis.

The present invention aims to meet this need by making available aprosthesis which is provided, on one of its faces, with a single markingmeans that is able to indicate both the centre of the prosthesis andalso the longitudinal direction of the latter.

The present invention relates to a prosthesis comprising a patch made ofbiocompatible material, said patch having a generally plane geometricshape that defines two opposite faces, a centre, a length and a width ofsaid patch, characterized in that said patch is provided, on one of itsfaces, with a single marking means designed to indicate both the centreof the patch and also the longitudinal direction of said patch.

According to the present application, a single marking means isunderstood as meaning that the marking means, regardless of whether itis continuous or non-continuous, is concentrated on a confined portionof the surface of the face of the patch on which it is present, suchthat the dimensions of this confined portion are of the order of thedimensions of the surgical field visible to the surgeon when fitting theprosthesis in place by laparoscopy. Thus, when the surgeon looks to findthe information he needs in order to position the prosthesis correctly,he does not have to move the prosthesis in several directions, which aresometimes divergent, before positioning the prosthesis in relation tothe defect to be treated. According to the invention, the single markingmeans is able to show the surgeon at just one glance, in the surgicalfield visible to the surgeon in implantation by laparoscopy, the face ofthe patch with which the surgeon is dealing, the centre of said patch,and the longitudinal direction thereof, in other words the direction ofits length.

In one embodiment of the invention, said marking means is chosen from asheet of biocompatible material, a coating of a biocompatible material,and combinations thereof.

The sheet of material can be, for example, a film, obtained by extrusionfor example, or a textile, or a combination of these. The coating ofmaterial can be obtained, for example, by painting on or spraying on asuitable material.

In one embodiment, said marking means has a shape whose perimetercombines the contours of a circular shape and of a generally elongateshape attached to said circular shape, the longitudinal axis of saidelongate shape being parallel to the longitudinal direction of saidpatch in the plane of said patch, and said circular shape comprising ameans for identifying its central point, said central point beingsituated at the centre of said patch.

Thus, when the surgeon sees the marking means in the field of viewavailable to him when fitting the prosthesis of the invention in placeby laparoscopy, he obtains the following information directly and at oneglance:

the face on which the marking means is situated: the surgeon knows,before implanting the prosthesis, if the marking means is situated onthe face of the patch intended to be placed facing the abdominal wallor, on the contrary, on the face of the patch intended to be placedfacing the abdominal cavity;the centre of the patch, generally corresponding to the centre of theprosthesis: the means for identifying the central point of the circularshape shows him the centre of the patch;the longitudinal direction of the patch, by means of the longitudinalaxis of the elongate shape.

For example, said means for identifying the central point of thecircular shape is formed by an absence of material in the sheet ofmaterial or in the coating of material at the location of the centralpoint of the circular shape.

For example, the elongate shape can have the shape of an arrow, a rod oran elongate triangle. By its nature, the elongate shape has two oppositeends in its longitudinal direction. The elongate shape can be attachedto the circular shape via either of its sides or via one of its ends.Preferably, said elongate shape is attached to said circular shape viaone of its ends.

In one embodiment, said marking means is made of bioabsorbable material.Such an embodiment makes it possible to limit the amount of foreignmaterial present long-term in the patient's body, while at the same timeallowing the surgeon to be provided with the information he needs forcorrectly positioning the prosthesis at the time of implantation.

Within the context of the present application, “bioabsorbable” or“biodegradable” means the characteristic by which a material is absorbedand degraded by the biological tissues and disappears in vivo after adefined period, which can vary, for example, from a few hours to severalmonths, depending on the chemical nature of the material.

Thus, the bioabsorbable materials suitable for the marking means of thepresent invention can be chosen from polylactic acid (PLA), polyglycolicacid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone(PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA),polyhydroxyalkanoates (PHAs), polyarnides, polyethers, copolymersthereof and mixtures thereof.

Alternatively, said marking means can be made of a non-bioabsorbablematerial. For example, in such an embodiment, the marking means canparticipate in strengthening the patch forming the prosthesis.

The non-bioabsorbable materials suitable for the marking means of thepresent invention can be chosen from polyethylene terephthalate (PET),polyarnides, aramids, expanded polytetrafluoroethylene, polyurethane,polyvinylidene difluoride (PVDF), polybutyl esters, polyetheretherketone(PEEK), polyolefins (such as polyethylene or polypropylene), copperalloys, silver alloys, platinum, medical grades of steel such asmedical-grade stainless steel, and combinations thereof.

In some embodiments of the invention, the marking means can be formedfrom a combination of bioabsorbable material and non-bioabsorbablematerial.

In one embodiment, said marking means has a colour different than thecolour of said patch. Such an embodiment allows the surgeon toimmediately and easily locate the marking means when implanting theprosthesis by laparoscopy.

In one embodiment of the invention, said patch is a textile, preferablyan openworked textile.

Within the context of the present application, “textile” is understoodas any textile obtained from an arrangement or assembly of biocompatibleyarns, fibres, monofilaments and/or multifilaments, for example a knit,weave, braid and/or non-woven, and having two opposite faces. Accordingto the present application, “openworked textile” is understood asmeaning that, on at least one of its faces, preferably the face intendedto be placed facing the abdominal wall, the textile comprises openings,cells, pores or holes, which open to the outside. Such openings promotethe penetration of the cells into the textile and thus promote the cellrecolonization of the prosthesis after implantation. In one embodiment,both faces of said textile are openworked.

The yarns or fibres or filaments and/or multifilaments forming thetextile according to the invention can be made from any biocompatiblematerial, whether bioabsorbable or non-bioabsorbable. The bioabsorbablematerials and non-bioabsorbable materials suitable for the yarns formingthe textile of the prosthesis patch according to the invention can bechosen from the materials cited above for the marking means.

The textile forming the prosthesis patch according to the invention canbe made from completely bioabsorbable yarns if it is intended todisappear after it has performed its reinforcing function during theperiod of cell colonization and tissue rehabilitation. In otherembodiments, it can comprise non-bioabsorbable yarns if the prosthesisis intended to act as a permanent reinforcement and to remaindefinitively in the body of the patient.

In one embodiment of the invention, the openworked textile of theprosthesis patch according to the invention is a knit. According to thepresent application, a knit is understood as an arrangement of yarnsobtained by knitting. The knit can be two-dimensional orthree-dimensional.

Within the context of the present application, a two-dimensional knit isunderstood as a knit having two opposite faces linked together by meshesbut devoid of a spacer: such a knit can be obtained, for example, byknitting yarns on a warp or Raschel knitting machine using twoneedle-guide bars. Examples of knitting two-dimensional knits suitablefor the present invention are given in document WO2009/071998.

According to the present application, a three-dimensional knit isunderstood as a knit having two opposite faces linked together by aspacer, said spacer itself being formed from additional linking yarns inaddition to the yarns forming the two faces of the knit. Such a knit canbe obtained, for example, on a double-bed warp or Raschel knittingmachine using several needle-guide bars. Examples of knittingthree-dimensional knits suitable for the present invention are given inthe documents WO99/05990, WO2009/031035 and WO2009/071998.

In one embodiment of the invention, said marking means is a textile,preferably an openworked textile, as has been defined above for thepatch forming the prosthesis.

When said patch and said marking means are both textiles, preferablyopenworked textiles, they can be identical or different. For example,referring to the definitions given hereinabove, said patch can be athree-dimensional knit and said marking means can be a two-dimensionalknit.

When said patch and said marking means are both textiles, said markingmeans can be sewn onto the face of said patch. Alternatively, saidmarking means can be glued onto the face of said patch.

In one embodiment, said marking means is situated inside a centralregion of said patch, the surface area of said central region being lessthan or equal to 20 cm², preferably less than or equal to 16 cm², morepreferably less than or equal to 7 cm².

Thus, when fitting the prosthesis in place by laparoscopy the surgeon,without having to move the prosthesis about, is able to discern directlyand easily from the single marking means, clearly visible to him withinthe surgical field, the centre of the prosthesis, the longitudinaldirection thereof and the face with which he is dealing.

In one embodiment, said patch, on its face provided with said markingmeans, is covered with an anti-adhesion coating, said coating likewisecovering said marking means. In such an embodiment, the marking means isthus present on the face of said patch forming the face of theprosthesis intended to be placed facing the abdominal cavity.

Within the context of the present application, “anti-adhesion” isunderstood as referring to a biocompatible material or coating that issmooth and non-porous, provides no space for cell recolonization andprevents the surrounding organs from attaching themselves to theprosthesis.

The anti-adhesion material or coating can be chosen from bioabsorbablematerials, non-bioabsorbable materials and mixtures thereof.

The non-bioabsorbable anti-adhesion coatings can be chosen frompolytetrafluoroethylene, polysiloxanes, polyurethanes, stainless steels,derivatives of precious metals, and mixtures thereof.

Said anti-adhesion material or coating is preferably bioabsorbable: thebioabsorbable materials suitable for said anti-adhesion coating can bechosen from collagens, for example oxidized collagen, oxidizedcelluloses, polyacrylates, trimethylene carbonates, caprolactones,dioxanones, glycolic acid, lactic acid, glycolides, lactides,polysaccharides, for example chitosans, polyglucuronic acids, hyaluronicacids, dextrans, fucans, polyethylene glycol, glycerol and mixturesthereof.

Upon implantation of the prosthesis according to the invention, theanti-adhesion coating makes it possible, at least during the initialphase of healing, to protect the textile of the prosthesis at the placewhere this anti-adhesion coating is present; thus, the covered face isnot exposed to inflammatory cells such as granulocytes, monocytes,macrophages or even the multi-nuclear giant cells that are generallyactivated by the surgery. Indeed, at least during the initial phase ofhealing, the duration of which can vary between 5 and 10 daysapproximately, only the anti-adhesion coating can be accessed by thevarious factors such as proteins, enzymes, cytokines or cells of theinflammatory line.

In the case when the anti-adhesion coating is made of non-absorbablematerials, it thus protects the textile before and after implantation,throughout the period of implantation of the prosthesis.

Moreover, by virtue of the anti-adhesion coating, the surroundingfragile tissues, for example the hollow viscera, are protected, inparticular from the formation of undesirable and serious post-surgicalfibrous adhesions.

In the case when the anti-adhesion material comprises a bioabsorbablematerial, it is preferable to choose a bioabsorbable material that isabsorbed only after a few days, so as to ensure that the anti-adhesioncoating can perform its function of protecting the surrounding organsduring the days after the operation and until the cell recolonization ofthe prosthesis in turn protects these organs.

In one embodiment, the anti-adhesion coating is in the form of abioabsorbable film.

In one embodiment, the anti-adhesion coating is in the form of abioabsorbable film that likewise covers the marking means, which isitself formed from a bioabsorbable material. Thus, once theanti-adhesion coating has been bioabsorbed, the marking means can inturn be bioabsorbed. This avoids an excessive amount of foreign materialremaining in the patient's body once the cell recolonization of theprosthesis has taken place.

The advantages of the present invention will become clearer from thefollowing description and from the attached drawings, in which:

FIG. 1 is a top view of a prosthesis according to the invention,

FIG. 2 is a top view of a variant of the marking means of the prosthesisof FIG. 1.

Referring to FIG. 1, this shows a prosthesis 1 according to theinvention seen from above. The prosthesis 1 is intended for the repairof a hernia, in particular as a reinforcement of the abdominal wall, oneof its faces being intended to be placed facing the abdominal wall, andits opposite face being intended to be placed facing the abdominalcavity. The prosthesis 1 comprises a patch 2 made of biocompatiblematerial, in the form of an openworked textile in the example shown. Anopenworked textile of this kind can be obtained by the methods describedin the documents WO99/05990, WO2009/031035 and WO2009/071998. Thetextile forming the patch 2 of the prosthesis according to the inventioncan be made of bioabsorbable yarns, of non-bioabsorbable yarns, or of acombination of bioabsorbable yarns and non-bioabsorbable yarns. Forexample, this textile is produced using yarns that are white in colour,for example non-bioabsorbable monofilament yarns of polyethyleneterephthalate (PET) with a diameter of 90 μm, such that the patch 2 islikewise white in colour.

The patch 2 has a generally plane geometric shape that defines said twoopposite faces, only one of these faces, i.e. the face 2 a intended tobe placed facing the abdominal cavity, being visible in FIG. 1.

In the example shown in FIG. 1, the patch 2 has a generally rectangularshape with a length L, in its longitudinal direction D, a width l, and acentre C. For example, the length L can be up to 42 cm, and the width lcan be up to 32 cm.

The patch 2 is provided, on its face 2 a, with a marking means in theform of an element 3 which is a sheet of material composed of abiocompatible textile. Alternatively, the sheet of material could be afilm of biocompatible material, obtained by extrusion for example.

In embodiments not shown, the element 3 in the form of a sheet ofmaterial could be replaced by an element obtained by depositing, on theface 2 a of the patch 2, a coating of a biocompatible material, forexample an ink, collagen, or any other natural or synthetic polymer,either absorbable or non-absorbable; for example, this deposit could beobtained by applying the face 2 a to the element, which is in solutionbefore forming a gel. Alternatively, the element could be applied bybeing sprayed or painted onto the face in question, for example in thecase of an ink.

In the example shown, the element 3 is formed by a textile. This textilecan be identical to or different than the one constituting the patch 2.In the example shown, the textile forming the element 3 differs fromthat forming the patch 2. In particular, the textile forming the element3 has a different colour than the white colour of the patch 2. Forexample, the textile forming the element 3 can be made of green-colourednon-bioabsorbable monofilament yarns of polyethylene terephthalate (PET)with diameter 90 μm. Therefore, in this example, the element 3 isnon-bioabsorbable.

Alternatively, the textile forming the element 3 can be made ofbioabsorbable yarns.

As will be seen from FIG. 1, the element 3 has a shape whose perimetercombines the contours of a circular shape 4 and of a generally elongateshape 5, which is attached to said circular shape 4. As is shown in FIG.1, the circular shape 4 has generally the shape of a ring, its centralpart 4 a being without material. The absence of material in the centralpart 4 a results in a difference in colour in relation to the rest ofthe circular shape 4, thus making it possible to quickly locate thecentral point 4 b of the circular shape, which central point 4 b of thecircular shape is coincident with the centre C of the patch 2 in theexample shown. Thus, the absence of material in the central part 4 a ofthe circular shape 4 constitutes a means for identifying the centralpoint 4 b of the circular shape and, accordingly, the centre C of thepatch 2 which, in the example shown, also corresponds to the centre ofthe prosthesis 1.

In the example shown, the elongate shape 5 has generally the shape of anelongate triangle, or of an arrow, such that its longitudinal axis A isparallel to the longitudinal direction D of the patch 2, in the plane ofthe patch 2. In the example shown, the elongate shape 5 is attached tosaid circular shape 4 via one of its ends. FIG. 2 shows a variant of theelement 3, in which the elongate shape 5 has the shape of an elongaterectangle and is attached to the circular shape 4 via one of its longsides.

The elongate shape 5 of the element 3 thus makes it possible todetermine automatically the longitudinal direction D of the prosthesis1, even if only a small portion of the prosthesis 1 is visible, namely alimited portion corresponding to its central region, without seeing theedges of the prosthesis.

Thus, the element 3 is situated inside a central region 6 (indicated bybroken lines in FIG. 1) of said patch 2, the surface area of saidcentral region 6 being less than or equal to 20 cm², preferably lessthan or equal to 16 cm², more preferably less than or equal to 7 cm².

When fitting the prosthesis 1 in place by laparoscopy, the surgeon,whose field of view is limited on account of the operating technique,cannot see the edges of the prosthesis 1, since they are situatedoutside his field of view. By contrast, he can see the whole of theelement 3. The specific shape of this element 3 provides him with all ofthe following information at one glance:

the face with which he is dealing: the surgeon knows, before implantingthe prosthesis, that the marking means, namely the element 3, issituated on that face of the patch 2 intended to be placed facing theabdominal cavity;

the centre of the patch 2, corresponding to the centre of theprosthesis:

the means for identifying the central point 4 b of the circular shape 4,namely the absence of material 4 a, by colour contrast shows the surgeonthe centre of the patch 2;

the longitudinal direction of the patch 2, by means of the longitudinalaxis A of the elongate shape 5.

The surgeon thus has all the information he needs in order to positionthe prosthesis 1 correctly, without having to move the prosthesis 1about to look for means of information situated at the periphery of thelatter.

In the example shown, the element 3 is sewn onto the textile face 2 a ofthe patch 2. Alternatively, it could be glued onto this face 2 a.

In an example not shown, the patch 2, on its face 2 a provided with theelement 3, is covered with an anti-adhesion coating, said coatinglikewise covering the element 3.

Such a coating makes it possible to limit or avoid the formation ofpost-surgical adhesions after implantation of the prosthesis. Forexample, this anti-adhesion coating is in the form of a bioabsorbablecollagen film, as described in WO9906080.

The prosthesis according to the invention allows a surgeon, whenimplanting a hernia prosthesis having a longitudinal dimension, to seeat one glance the whole of a marking means for indicating to the surgeonthe face of the prosthesis to be placed facing the abdominal cavity, thelongitudinal direction of the prosthesis, and the centre of theprosthesis. The manoeuvres involved in positioning the prosthesis inrelation to the defect to be treated and to the surrounding organs aregreatly facilitated.

The invention claimed is:
 1. A prosthesis comprising a first textile made of a first biocompatible material, said first textile having a first generally plane geometric shape that defines a first face and a second face opposite the first face and a second open-worked textile made of a second biocompatible material, said second open-worked textile positioned on at least the first face of the first textile, said second open-worked textile having a second generally plane geometric shape including a perimeter surrounding a center of the first face of the first textile and designed to indicate both the center and a longitudinal direction of the first face of the first textile, said second open-worked textile including a part absent of material, the part located on the center of the first face of the first planar textile, wherein the perimeter of the shape of the second open-worked textile combines a circular shape and a generally elongate triangular shape attached to said circular shape.
 2. The prosthesis according to claim 1, wherein the first textile is an open-worked textile.
 3. The prosthesis according to claim 1, wherein the first textile is a three-dimensional textile.
 4. The prosthesis according to claim 3, wherein the second open-worked textile is a two-dimensional knit.
 5. The prosthesis according to claim 1, wherein the first biocompatible material is a bioabsorbable material.
 6. The prosthesis according to claim 5, wherein the second biocompatible material is a non-bioabsorbable material.
 7. The prosthesis according to claim 1, wherein the first generally plane geometric shape of the first textile is generally parallel to the second generally plane geometric shape of the second open-worked textile.
 8. The prosthesis according to claim 1, wherein a longitudinal axis of the elongate shape is parallel to the longitudinal direction of the first face of the first textile.
 9. The prosthesis according to claim 1, wherein the elongate shape is attached to the circular shape via one end of the elongate triangle.
 10. The prosthesis according to claim 1, wherein the part absent of material of the second open-worked textile is a central part of the circular shape.
 11. The prosthesis according to claim 1, wherein the second open-worked textile has a color different than a color of the first textile.
 12. The prosthesis according to claim 1, wherein the second open-worked textile is sewn onto the first face of the first textile.
 13. The prosthesis according to claim 1, wherein the second open-worked textile is glued onto the first face of the first textile.
 14. The prosthesis according to claim 1, wherein the second open-worked textile is positioned with a central region of the first textile, wherein the central region includes a surface area of less than or equal to 20 cm².
 15. A prosthesis comprising a first textile made of a bioabsorbable material, said first textile having a first generally plane geometric shape that defines a first face and a second face opposite the first face and a second open-worked textile made of a non-bioabsorbable material, said second open-worked textile positioned on at least the first face of the first textile, said second open-worked textile having a second generally plane geometric shape including a perimeter surrounding a center of the first face of the first textile and designed to indicate both the center and a longitudinal direction of the first face of the first textile, said second open-worked textile including a part absent of material, the part located on the center of the first face of the first planar textile. 